The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function

January 17, 2025 updated by: Abbisko Therapeutics Co, Ltd

An Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function

This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control subjects with normal hepatic function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects should understand the study procedures and sign the informed consent form prior to Screening.
  2. Subjects must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
  3. Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 18 and 32 (inclusive), BMI = weight (kg)/height (m)2.
  4. Serum creatinine (Cr) ≤ 1.5 × ULN, or Creatinine clearance (Crcl) ≥ 60 mL/min (Cockcroft-Gault formula).

Exclusion Criteria:

  1. Known allergy or hypersensitivity to any components of the investigational drug product;
  2. Has a history of cancer in five years (malignancy), exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinomas in situ;
  3. Has factors that significantly affect the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small bowel resection, etc.
  4. Has a history of portosystemic shunt.
  5. Participation in any clinical study of an investigational drug/device within 3 months of the drug prior to Day -1;
  6. Received live vaccines or live-attenuated virus vaccine within 3 months prior to screening, or plan to get vaccinated during the study;
  7. Previously participated in this study or any other study related to pimicotinib and received pimicotinib;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The mild (Child-Pugh score 5 to 6) hepatic impairment.
Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.
Drug: Pimicotinib
Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.
Experimental: The moderate (Child-Pugh score 7 to 9) hepatic impairment.
Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.
Drug: Pimicotinib
Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.
Experimental: The healthy subjects.
Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.
Drug: Pimicotinib
Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
AUClast
Time Frame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
AUC 0-∞
Time Frame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbisko Therapeutics Co, Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yanan Wang, Doctor, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABSK021-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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